Tackling white coat syndrome by re-thinking patient-facing technology

For some patients, clinical site visits are an anxiety inducing experience. Not only can this emotional response affect trial data, it can also impact the retention and compliance of patients.

Patient-facing technologies, from wearable devices to electronic patient reported outcomes, have the potential to significantly increase the ability to collect data with minimal disruption to the patient.

Matthew Moyer, Director of Clinical Supply Technology at Merck and leader of the Transcelerate patient technology initiative, believes that by capturing more data that is representative of the patient’s full experience, we can better understand the impact of the trial. He cautions though that without a clear purpose and implementation plan, you can fall for the shiny object appeal and fail to gain real operational benefits.

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Pharma IQ: What is the benefit of using patient-facing technology within a clinical trial?

Moyer: Patient-facing technology offers a two-fold benefit.

From a sponsor perspective, it can improve understanding of the disease state and share the context of a patient’s journey as they participate in a trial. For sponsors, it’s really useful to have tools which offer better information on a patient’s natural environment.

From a patient perspective, it offers convenience by eliminating or reducing some of the participation burden as data can be gathered remotely.

We often face the “white coat syndrome”, where people are uncomfortable with the process of going to a clinic or dealing with a doctor. It can create a Pavlovian response of angst and anxiety, which can actually muddle the data coming from a trial or a patient’s response to the therapy they’re on.

If you can use patient-facing technology to increase the comfort of patients and reduce the participation burden, you can gain a far better understanding of what is going on with a patient.

If you can remove that emotional response and reduce the participation burden by collecting your data remotely, then you can gain a far better understanding of what is going on with a patient. You can also gather samples far more frequently without an additional burden to the patient.

So you gain a better and richer data set and can improve the patient experience.

Pharma IQ: How do you move forward with a patient-facing technology implementation?

Moyer: Firstly, you need to fully understand the problem you are facing and your intentions. Are you trying to gain a certain insight? Are you looking to reduce the patient burden? Is it a combination?

You then take that problem statement and apply a methodical and experimental approach to the pilot scale where you can test at a very small scale. During this test,
you want to understand if you can really address the problem statement with patient-facing technology.

You then pursue a very structured scaling approach that includes engaging with the appropriate stakeholders and understanding operational considerations for deployment.

"If you don’t start with the problem statement in mind, you might be ignoring key challenges that will show when it comes to the scale up.”

It really is a building block process. You start with your problem statement, understanding and developing a pilot to test the hypothesis. Then you build on that by engaging the appropriate stakeholder groups both inside the company and out.

One thing you need to look out for is the shiny object approach; finding a cool, new technology and trying to find a way to apply it to your trial.

If you don’t start with that problem statement in mind, you might be ignoring key challenges that will show when it comes to scaling up the technology. You might also lose sight of the problem you’re trying to solve if your focus is only on the new gadget you want to use.

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Pharma IQ: How do you address pushback from stakeholders when introducing new technology to a trial?

Moyer: It’s really all about being able to speak the language of impact to each stakeholder in the trial. You need to demonstrate viably how to install the technology
and the why behind it. If you can articulate it both from an industry perspective and a patient perspective, it will help you tell the full story a bit better.

You will always face people who have a knee jerk response of don’t mess with my trial. People can be caught up in the idea that things are working as they are so don’t mess with them. To overcome that barrier, you really need to focus on how patient-facing technology will benefit the patient.

You need to show the benefits of patient-facing technology from both an industry and a patient perspective.

Some might also be concerned by the first mover cost from investing during a period of uncertainty. But you can remove some of these concerns by highlighting that you are not the first company to do this. If you can also point them to best practices and guidelines you can facilitate a much easier installation.

There are some important lessons to be learned through each pilot which will allow you to shape, craft and then reshape your approach to future trials. We tend to leverage roadshow-style presentations to explain what we’re doing and our thought process to improve learning across the organization.

The TransCelerate Patient Technology Initiative also developed a toolkit inclusive of an implementation framework, discussion guide, regulatory landscape tool and site feedback questionnaire. The framework in particular outlines a practical approach to developing a PT implementation plan and encourages a mindset of strategic thinking, rapid learning and patient-centric design.

Pharma IQ: What excites you most about the ongoing use of patient facing technology within clinical trials?

Moyer: Being able to capture more data that’s more representative of the patient’s true situation and true quality of life in a non-invasive and non-burdensome way.

It’s exciting when we really get that snapshot of what that patient is facing in reality. Not just insight from their visit to an artificial environment, where they may have spent an hour travelling to the site to see a doctor they don’t know well. Patient-facing technology allows us to gather insight in a comfortable environment for the patient.

We can use that data in a meaningful way to share our understanding of the drug and its impact in the trial. I think within the next couple years we could see a shift towards more remote clinical trials, especially with the ability to enable remote connectivity and in situ data gathering. With more advances towards non-burdensome data collection, we’ll see that shift from a traditional structure towards something that is a bit more convenient for the patient.

With patient-facing technology, we have an opportunity to capture data that is more representative of a patient’s true situation in a non-invasive and non-burdensome way.